跳至主要内容
临床试验/CTRI/2024/02/062631
CTRI/2024/02/062631已完成不适用

Evaluating the efficacy of intra-articular Platelet Rich Plasma (PRP) injection on pain, function and post traumatic temporomandibular joint dysfunction in patients with unilateral condylar fracture of mandible.

JSS Academy of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
1) maximum mouth opening ( Measured by inter-incisal distance)

研究概览

简要总结

Condylar fractures are a commonly encountered problem in oral and maxillofacial surgery, and its treatment has always been a topic of debate. Research is always ongoing to reach a consensus for a set treatment protocol for providing optimum functional outcome. In the interest of bettering patient outcomes in condylar fractures, this study aims to evaluate the efficacy of intra articular injection of Platelet Rich Plasma in improving pain, function, need for secondary treatment and post traumatic Temporomandibular Joint dysfunctions in patients with unilateral condylar fractures of mandible.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Unilateral condylar head and high neck condylar fractures of mandible (based on AO classification) 2)Adults above the age of 18yrs and up to 60 years of age.
  • Patients consenting for the study.

排除标准

  • Low condylar neck or sub condylar fractures (According to AO classification) 3)Patients below the age of 18 yrs and above the age of 60 years.
  • Patients with pre-existing Temporomandibular Joint disorders.

结局指标

主要结局

1) maximum mouth opening ( Measured by inter-incisal distance)

时间窗: 1) Baseline | 2) 4 weeks | 3) 6 weeks | 4) 3 months

2) Pain score from 0-10 ("0" being no pain and "10" being worst possible pain)

时间窗: 1) Baseline | 2) 4 weeks | 3) 6 weeks | 4) 3 months

3) The need for a second round of intermaxillary fixation was recorded ( As Yes or no)

时间窗: 1) Baseline | 2) 4 weeks | 3) 6 weeks | 4) 3 months

次要结局

  • Incidence of post traumatic Temporomandibular joint disorders(As yes or no)(3 month follow up-Incidence of post traumatic Temporomandibular joint disorders)

研究者

发起方
JSS Academy of Higher Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Revati Kale

JSS Dental College and Hospital

研究点 (1)

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